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Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study. (BreCaLip)

Primary Purpose

Breast Cancer, Lipid Cell; Tumor, Nutrition Related Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lipidomic analysis for breast cancer patients
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Patients Age <65 years (not to have influence on functioning of desaturase enzymes that decline with older ages). Neoplastic pathology: primary invasive breast cancer or ductal in situ (DCIS) newly diagnosed, in the pre-operative phase and which has not already undergone chemo- or radiotherapy. Absence of serious intestinal and hepatic pathologies, diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic affection, thyroid affections in pharmacological treatment. Absence of supplementation with omega-3 based supplements for at least 6 months. Homogeneous distribution by BMI (1:1 ratio subjects with BMI≥25 and BMI<25, respectively). Informed consent to participate in the study. controls Age <65 years; Not be affected by cancer; BMI <25kg/m2; Informed consent to participate in the study Exclusion Criteria: patients Age ≥65 years (would affect the functioning of desaturase enzymes that decline with older age). Invasive primary breast cancer or ductal in situ (DCIS) previously treated with chemo- or radiotherapy. Metastasis at diagnosis. Presence of serious intestinal and hepatic pathologies. Presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic disease, thyroid disease in pharmacological treatment. Supplementation with omega-3 based supplements for at least 6 months. Failure to sign the informed consent to participate in the study. controls Age ≥65 years; Suffering from tumor pathology; BMI ≥25kg/m2; Refusal to sign informed consent to participate in the study.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention arm (breast cancer)

Control arm (healthy subject)

Arm Description

Lipidomic analysis for breast cancer patients

Lipidomic analysis for healthy subjects

Outcomes

Primary Outcome Measures

Correlation lipidome and BMI
Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc…) according to the BMI class considered.

Secondary Outcome Measures

Correlation lipidome and nutrition/anatomical-pathological
Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample.

Full Information

First Posted
August 10, 2023
Last Updated
September 4, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT06026631
Brief Title
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Acronym
BreCaLip
Official Title
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
August 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to learn about breast cancer lipodome signature in patients waiting for surgery with different Body Mass Index. The main question it aims to answer are: To highlight a specific lipidome molecular signature for breast cancer patients overweight and obese (BMI > 25 Kg/m2) compared with patients of normal weight (BMI<25 kg/m2). Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological data of breast cancer patients and the correlation between molecular profile and body weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lipid Cell; Tumor, Nutrition Related Cancer, Body Weight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm (breast cancer)
Arm Type
Experimental
Arm Description
Lipidomic analysis for breast cancer patients
Arm Title
Control arm (healthy subject)
Arm Type
Other
Arm Description
Lipidomic analysis for healthy subjects
Intervention Type
Procedure
Intervention Name(s)
Lipidomic analysis for breast cancer patients
Intervention Description
Lipidomic analysis for breast cancer patients
Primary Outcome Measure Information:
Title
Correlation lipidome and BMI
Description
Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc…) according to the BMI class considered.
Time Frame
First day
Secondary Outcome Measure Information:
Title
Correlation lipidome and nutrition/anatomical-pathological
Description
Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample.
Time Frame
First day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients Age <65 years (not to have influence on functioning of desaturase enzymes that decline with older ages). Neoplastic pathology: primary invasive breast cancer or ductal in situ (DCIS) newly diagnosed, in the pre-operative phase and which has not already undergone chemo- or radiotherapy. Absence of serious intestinal and hepatic pathologies, diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic affection, thyroid affections in pharmacological treatment. Absence of supplementation with omega-3 based supplements for at least 6 months. Homogeneous distribution by BMI (1:1 ratio subjects with BMI≥25 and BMI<25, respectively). Informed consent to participate in the study. controls Age <65 years; Not be affected by cancer; BMI <25kg/m2; Informed consent to participate in the study Exclusion Criteria: patients Age ≥65 years (would affect the functioning of desaturase enzymes that decline with older age). Invasive primary breast cancer or ductal in situ (DCIS) previously treated with chemo- or radiotherapy. Metastasis at diagnosis. Presence of serious intestinal and hepatic pathologies. Presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic disease, thyroid disease in pharmacological treatment. Supplementation with omega-3 based supplements for at least 6 months. Failure to sign the informed consent to participate in the study. controls Age ≥65 years; Suffering from tumor pathology; BMI ≥25kg/m2; Refusal to sign informed consent to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Magno, MD
Phone
+39 06 3015 7077
Email
stefano.magno@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio Filippone, Ph.D.
Phone
+39 06 3015 7077
Email
alessio.filippone@guest.policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Magno, MD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano magno, MD
Phone
+39 0630157077
Email
stefano.magno@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Alessio Filippone, Ph.D.
Phone
+39 0630157077
Email
alessio.filippone@guest.policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Stefano Magno, MD
First Name & Middle Initial & Last Name & Degree
Riccardo Masetti, MD
First Name & Middle Initial & Last Name & Degree
Alessio Filippone, Ph.D.
First Name & Middle Initial & Last Name & Degree
Cristina Rossi, Ph.D.
First Name & Middle Initial & Last Name & Degree
Maria M Rossi, M.Sc.
First Name & Middle Initial & Last Name & Degree
Claudia Maggiore, MD
First Name & Middle Initial & Last Name & Degree
Annalisa Di Micco, MD
First Name & Middle Initial & Last Name & Degree
Luana Forcina, M.Sc.

12. IPD Sharing Statement

Plan to Share IPD
No

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Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.

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